Oral Lichen Planus
Conditions
Keywords
oral lichen planus, probiotics, clobetasol probionate
Brief summary
Oral lichen planus patients who will meet inclusion criteria will be divided into 2 groups -The intervention group (Group P): This group will be randomly allocated to take one capsule twice daily during meal time at morning and evening of probiotics complex obtained from Biovea for 4 -week study period. Moreover, patients in this group will be instructed to apply clobetasole propionate in orabase gel 2 times daily for 4 weeks. Patients will receive their supply of the gel and probiotics every 2 weeks. The control group (Group B): This group will be randomly allocated to apply clobetasol propionate in orabase gel 4 times daily after meal times and before sleeping for 4 weeks. At the 3rd week this group will be instructed to apply miconazole gel 4 times daily as a prophylaxis for two weeks. Salivary sample collection: Unstimulated salivary sample was collected from all participants twice , once at baseline and another time after 4 weeks from the study period. Saliva was collected in graduated clear test tubes to be used in the evaluation of candidal counts before and after treatment . Patient's visits was at baseline, 2 weeks and 4 weeks.
Interventions
DRUGProbiotic Blend Oral capsules
probtiotic bend oral tablets from biovia will be adminestrated containing 4 strains ( twice daily) in addition to topical clobetasol application twice daily
DRUGCorticosteroids for Local Oral Treatment
topical clobetasol probionate in orabase application 4 times daily
Sponsors
Cairo University
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are diagnosed with symptomatic lichen planus whether bullous erosive or erythematous oral lichen planus. * Male or female patient with age range between 20-75 years old were included. * medically free individuals
Exclusion criteria
* the use of systemic antibiotics, corticosteroids or immunosuppressive agents within four weeks prior to enrollment in the study. * Pregnant females * patients with history of systemic disorder affecting the immune system * active liver diseases and cancer * allergy or intolerance to probiotics. * any other oral lesions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| size wound | 0 , 2 weeks and 4 weeks | thongprasom scale |
| Pain in oral cavity | 0 , 2 weeks and 4 weeks | Numerical rating scale (0-10) 0= minimal pain 10 unbearable pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| candidal load assessment | 0 and 4 weeks | culturing technique in CFU unit |
Countries
Egypt
Contacts
Primary ContactAmira Abdelwhab, lecturer
Outcome results
None listed